A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

NCT02268201 | Terminated Phase 4

• 1 other identifier: ACNKTxCon
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 7

Brief Summary

KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.

Conditions

Kidney Transplant Recipients

Keywords

tacrolimus; immunosuppressive therapy

Outcome Measures

Primary Outcomes (1)

• medication adherence

  VAS will be used to evaluate adherence between PRG and ADV

  Up to 52 weeks after switching

Secondary Outcomes (6)

• endogenous creatinine clearance rate (Ccr)

  Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52

• Calculated glomerular filtration rate

  Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52

• blood lipids

  Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52

• liver function (AST, ALT and bilirubin)

  Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52

• fasting blood-glucose (FBG)

  Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52

Study Arms (2)

ADV group

EXPERIMENTAL

Once daily

Drug: Advagraf

PRG group

EXPERIMENTAL

Twice daily

Drug: Prograf

Interventions

Advagraf DRUG

oral

Also known as: Tacrolimus prolonged-release capsule

ADV group

Prograf DRUG

oral

Also known as: Tacrolimus capsule

PRG group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months， and have maintained a stable regimen for at least 8 weeks before enrollment
• The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment
• SCr\< 200 μmol/l ( 2.3 mg/dl)
• Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study
• Understand and sign the approved informed consent form

You may not qualify if:

• Patients who have had other solid organ transplantations
• hours proteinuria\>2g
• SGPT/ALT，SGOT/AST or total bilirubin rising to more than double the normal level
• Patients suffering from serious infection lesions
• Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption
• Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history
• Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients
• Pregnancy or lactating women
• Patients have participated in another clinical trial in the past month
• Patient refuses to sign informed consent form
• Patient not willing to continue in the study and wants to withdraw from the study
• Poor adherence or lost to follow-up
• Violation of protocol
• Severe adverse events occurred need to withdraw the study according to investigator's judgment
• Pregnancy

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (7)

Unknown Facility

Beijing, China

Location

Unknown Facility

Fuzhou, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Jinan, China

Location

Unknown Facility

Nanchang, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Xi'an, China

Location

Related Links

• Link to results on the Astellas Clinical Study Results website

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2014
• First Posted: October 20, 2014
• Study Start: July 23, 2013
• Primary Completion: March 31, 2015
• Study Completion: March 31, 2015
• Last Updated: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)